NCT05230355

Brief Summary

The aim of this study is to assess the results of subliminal subthreshold transscleral diode cyclophotocoagulation in refractory glaucoma using the standard technique of 360 degree application and to compare the outcome with a modified technique both in terms of efficacy and safety.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

July 10, 2025

Status Verified

January 1, 2022

Enrollment Period

2.5 years

First QC Date

January 20, 2022

Last Update Submit

July 6, 2025

Conditions

Refractory Glaucoma

Outcome Measures

Primary Outcomes (1)

  • IOP reduction success rate

    Success rate is defined as achieving an IOP between 5 and 21 mmHg or at least a 20% reduction in IOP at the final follow up with or without IOP lowering medications

    6 months

Study Arms (2)

group A the standard technique

ACTIVE COMPARATOR

The tip of the probe was moved in a "painting" motion along the upper and lower hemispheres over pars plana, 3 mm behind the limbus, avoiding the 3 and 9 o'clock positions.

Device: standard technique

Group B a modified technique

ACTIVE COMPARATOR

The probe tip was moved for 2 mm perpendicular to a line 3 mm parallel to the cornea, aiming to cover the largest circumference of the ciliary body area.

Device: modified pattern

Interventions

standard techniqueDEVICE

The probe was moved over each hemisphere for 120 seconds (a total of 240 seconds). Total energy = 2.5 x 0.313 x 240 = 187.8 J

group A the standard technique
modified patternDEVICE

The probe was moved over 3 quadrants for 80 seconds for each quadrant (a total of 240 seconds). Total energy = 2.5 x 0.313 x 240 = 187.8 J

Group B a modified technique

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with refractory glaucoma (IOP \> 21 mmHg unresponsive to maximally tolerated antiglaucoma medications, previously failed surgical treatment, or both)

You may not qualify if:

  • Ocular inflammation.
  • Ocular infection.
  • Recent ocular surgery in the study eye in the 2 months prior to enrolment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of ophthalmology

Study Record Dates

First Submitted

January 20, 2022

First Posted

February 8, 2022

Study Start

February 1, 2022

Primary Completion

August 1, 2024

Study Completion

February 1, 2025

Last Updated

July 10, 2025

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)